Thol'Impilo: Bringing People Into Care

HIV Clinical Trial

Official title:

An Evaluation of Strategies to Accelerate Entry-into-care Following HIV Diagnosis Among Adults in Gauteng and Limpopo Provinces, South Africa

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02271074
• Other study ID #: AUR5-9-119
• Secondary ID: AID-OAA-A-12-000
• Status: Completed
• Phase: N/A
• First received: October 14, 2014
• Last updated: July 19, 2016
• Start date: June 2012
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: The Aurum Institute NPC
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Africa: Department of HealthSouth Africa: Human Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The main objective of this study is to compare the effectiveness of combinations of three patient-oriented strategies, compared to the standard of care, to increase the proportion of patients who enter-into-care for HIV within 90 days of testing HIV positive.

Description:

Background:

Mortality remains high among individuals with HIV in South Africa largely due to low CD4 at initiation of combination antiretroviral therapy (cART) or failure to initiate cART altogether. The problem of advanced HIV at the time of entry-into-care persists despite increases in CD4 count initiation thresholds and higher CD4 counts among individuals testing HIV positive at HIV counselling and testing services (HCT). A reason for the discord between CD4 at HCT and CD4 at cART initiation is a failure to effectively link people who test positive into HIV care; less than half of individuals testing HIV positive enter HIV care within 3-6 month of HIV diagnosis. However, not only do these delays increase HIV associated mortality, delays from testing positive to entry-into-care for HIV also reduces the ability of test-and-treat strategies to reduce HIV transmission through HIV treatment.

Study Design:

Thol'impilo is an open (non-masked) individually-randomized implementation science evaluation of the effectiveness and cost-effectiveness of combinations of three strategies to increase timely entry-into-care for HIV compared to the standard of care. Participants are randomly assigned to one of four arms to increase timely entry into care: (1) standard of care, (2) point-of-care CD4 and transport assistance, (3) point-of-care CD4 and care facilitator and (4) point-of-care CD4 alone.

Sample size:

The study aims to enrol 2500 participants (i.e. 650 participants per arm).

Setting:

The study is built onto the current community-based HIV Counselling and Testing (HCT) services. The HCT units serve peri-urban townships and informal settlements, rural farm workers, and both urban and rural communities.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2398
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• aged 18 years and older, diagnosed HIV positive at enrolling mobile HCT units, no prior self-reported registration at a health care facility for HIV care, provide consent for participation

Exclusion Criteria:

• self-reported prior or current registration as an HIV patient at a healthcare facility

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• HIV

Intervention

Other:
• Point of care CD4 testing
Participants in this arm will receive POC CD4 testing using the PIMA™ CD4 test system. Results will be made available to the participant within 20 to 25 minutes, before the participant leaves the HCT room. Participants will be given a copy of their results, which will be affixed to their referral letter, and they will be educated on the meaning of the CD4 results in relation to their health. This session will only be performed once at the time of issuing POC CD4 results.

Behavioral:
• Care Facilitation
The goal of this intervention is to provide on-going counselling using a combination of motivational and strengths-based counselling approaches.This is a time limited intervention with a maximum of 5 client sessions over a 90-day period. Participants will also be transitioned out of the intervention upon successful entry into HIV care. Sessions will be done using both face-to-face and telephonic approaches, although the former is more preferred.

Other:
• Transport support
The goal of this intervention is to address one of the most frequently noted structural barrier to entry-into-care in resource constrained settings: prohibitive distance or transport cost to reach a health facility.This is a time limited intervention with a maximum of 3 transport assists for healthcare visits over a 90-day period. Transport assistance is provided in the form of reimbursements to claims submitted by the participant after a self-reported HIV care clinic visits. Participants in this arm, receive their transport support through in-person collection or via cell phone transfer. Transport support amounts are standardised according to geographical area.

Locations

Country	Name	City	State
South Africa	The Aurum Institute NPC	Johannesburg	Gauteng

Sponsors (5)

Lead Sponsor	Collaborator
The Aurum Institute NPC	Johns Hopkins University, London School of Hygiene and Tropical Medicine, United States Agency for International Development (USAID), University of Witwatersrand, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time to ART initiation	To compare the proportion of cART-eligible patients who initiate cART within 90 days of study enrolment in each study arm.	90 days	No
Primary	Time to entry into HIV care	To compare the time to entering HIV care in each intervention arm against the standard of care arm over a 90 day period from study enrolment.	90 days	No
Secondary	Proportion entering care	To compare the proportion of participants in each arm entering care by 90 days from study enrolment	90 days	No
Secondary	Time to entry into HIV care	To compare the time to entering HIV care in each intervention arm against the standard of care over a 180 day period from study enrolment.	180 days	No
Secondary	Mortality	To compare time to mortality from enrolment by arm over a 12 month period	6 and 12 months	No
Secondary	Cost per additional participant entering into care	To evaluate the incremental cost effectiveness (cost per additional participant entering into care by 90 days) for each intervention arm compared to the standard-of-care	Costs will be measured over a 12 month horizon and entry into care will be measured over a 90 day period	No